- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00948805
Evaluation of the Luteolytic Effect of a Gonadotropin Releasing Hormone (GnRH) Agonist After the Administration of Human Chorionic Gonadotropin (hCG) in the Initial Follicular Phase a Its Influence on the Prognosis of in Vitro Fertilization Treatment
July 28, 2009 updated by: University of Sao Paulo
This study was designed to evaluate the ability of gonadotropin releasing hormone (GnRh) agonist to prevent the rise of progesterone during controlled ovarian stimulation for in vitro fertilization (IVF) after the administration of human Chorionic Gonadotropin (hCG) on the first day of menses.
Study Overview
Detailed Description
The aim of this study is to evaluate the efficacy of a GnRH agonist in preventing the functional rescue of corpus luteum in women submitted to controlled ovarian stimulation with administration of hCG on the first day of menses and to evaluate its effect on pregnancy rate and ovarian steroidogenesis.
Study Type
Interventional
Enrollment (Anticipated)
25
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Cláudia M Gomes, MD
- Phone Number: 551130596122
- Email: cgomes@huntington.com.br
Study Contact Backup
- Name: Andre M Rocha, PhD
- Phone Number: 551130596122
- Email: arocha@huntington.com.br
Study Locations
-
-
-
São Paulo, Brazil, 05403000
- Recruiting
- Assisted Reproduction Center "Governor Mário Covas" of the Faculty of Medicine of the University of São Paulo
-
Contact:
- Cláudia Gomes, MD
- Phone Number: 551176569373
- Email: cgomes@huntington.com.br
-
Principal Investigator:
- Cláudia Gomes, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 38 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- age >21 and < 38 years old
- polycystic ovarian syndrome
- risk for ovarian hyperstimulation syndrome
Exclusion Criteria:
- recurrent abortion
- endometriosis
- more than 3 IVF failures
- use of oral contraceptive pills in the preceding 3 months
- low response to gonadotropins
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: GnRH agonist
3,6 mg of goserelin acetate (GnRH agonist) will be administered on the 21st day of the menstrual cycle previous to ovarian stimulation.
250 mg of hCG will be administered on the first day of menses and a starting dose of 150 IU of FSH will be started 2 days later as a part of a long ovarian stimulation protocol.
Ovulation will be triggered with a 250 mg of hCG when at least 2 follicles attain 18mm and to accommodate oocyte retrieval within 36 hours.
|
3,6mg of goserelin acetate, 250mg of hCG, FSH variable dose according to the number of days required for appropriate ovarian stimulation
Other Names:
|
Active Comparator: Control
250 mg of hCG will be administered on the first day of menses and a starting dose of 150 IU of FSH will be started 2 days later as a part of a long ovarian stimulation protocol.
Ovulation will be triggered with a 250 mg of hCG when at least 2 follicles attain 18mm and to accommodate oocyte retrieval within 36 hours.
|
250mg of hCG, Zoladex, FSH variable dose according to the number of days required for appropriate ovarian stimulation
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Frequency of functional rescue of corpus luteum
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pregnancy rate
Time Frame: 6 months
|
6 months
|
Levels of serum steroids
Time Frame: 6 months
|
6 months
|
Levels of serum gonadotropins
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Paulo Serafini, PhD, Gynecology of Faculty of Medicine of University of SãoPaulo (Disciplina de Ginecologia da Faculdade de Medicina da Universidade de São Paulo)
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2009
Primary Completion (Anticipated)
December 1, 2009
Study Completion (Anticipated)
July 1, 2010
Study Registration Dates
First Submitted
July 23, 2009
First Submitted That Met QC Criteria
July 28, 2009
First Posted (Estimate)
July 29, 2009
Study Record Updates
Last Update Posted (Estimate)
July 29, 2009
Last Update Submitted That Met QC Criteria
July 28, 2009
Last Verified
July 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0555/09
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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